Skip to content

Supplementation with Multiple Micronutrients Intervention Trial

Supplementation with Multiple Micronutrients Intervention Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34151616
Enrollment
42000
Registered
2005-03-31
Start date
2001-07-01
Completion date
Unknown
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal and infant mortality and morbidity, and birth weight Pregnancy and Childbirth

Interventions

Initial study: Prenatal supplementation with either iron and folate or with a multivitamin containing iron, folate, vitamins A, B1, B2, B6, B12, C, D and E, along with niacin, zinc, co

Sponsors

Helen Keller Int., Gov. of Indonesia, Prov. Gov. of NTB, Dis. Govs of Lombok, U of Mataram, Mataram Hospital, Johns Hopkins Univ
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pregnant women and their infants. Inclusion criteria: Confirmed pregnancy of any gestational age by physical exam or urine test and consenting to be involved in the study.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
1. Miscarriage 2. Stillbirth 3. Perinatal mortality 4. Neonatal mortality 5. Early neonatal mortality 6. Late neonatal mortality 7. Infant mortality 8. Maternal mortality 9. Preterm birth 10. Birthweight 11. Low birthweight

Secondary

MeasureTime frame
Current secondary outcome measures as of 31/12/2014: 1. Child motor, cognitive, and socio-emotional development and health and morbidity at 9-12 years 2. Child anthropometry and nutritional status at 9-12 years 3. Child hemoglobin concentration at 9-12 years 4. An adapted version of the Home Observation for the Measurement of the Environment (HOME) as an indicator of the household cognitive development environment at 9-12 years 5. Maternal socio-emotional status at 9-12 years 6. Child biochemical nutritional status and biochemical markers of stress and immune function at 9-12 years 7. Child activity level, physiologic regulation and anatomical complexity at 9-12 years Previous secondary outcome measures as of 03/03/2011: 1. Maternal Cognition and Mood 2. Child Motor, Cognitive, and Socio-Emotional Development and Health and Morbidity at age 42 months 3. Child Anthropometry and nutritional status, including dietary habits, at age 42 months 4. Child Hemoglobin concentration at age 42 months 5. An adapted version of the Home Observation for the Measurement of the Environment (HOME) as an indicator of the household cognitive development environment 6. Weight gain during pregnancy 7. Maternal biochemical nutritional status and biochemical markers of pregnancy progression Previous secondary outcome measures: 1. Hemoglobin levels a. At 36 weeks gestational age b. Within 1 week of birth c. At 12 weeks post-partum d. Within 1 month of enrollment by 1st, 2nd, and 3rd trimester of enrollment 2. Gestational age 3. Head circumference 4. Maternal and infant morbidity 5. Cause of death

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026